Expanded Access to Immunomodulatory AVM0703 for Solid Tumor and Blood Cancer Patients

NCT ID: NCT05974410

Last Updated: 2025-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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AVM Biotechnology, Inc., provides immunomodulatory AVM0703 to solid tumor and blood cancer patients upon request by a US licensed MD or DO. As of July 2024, 37 patients have been treated through this FDA-EAP including patients diagnosed with relapsed or recurring glioblastoma, inoperable/chemotherapy ineligible CNS Squamous Cell Carcinoma, metastatic Breast Cancer, ovarian cancer, gastric cancer, Hodgkin's Lymphoma, Mixed Phenotype Acute Myelogenous Leukemia, colon cancer, B-ALL, Malignant Myxoid Spindle Cell Neoplasm, non-small cell lung cancer, DLBCL with CNS involvement, metastatic prostate cancer, Anaplastic T-cell Non-Hodgkin's Lymphoma and metastatic pancreatic cancer. Drug-related side-effects are predominantly grade 1 and include itching during the infusion and about 1 week of low grade insomnia.

Detailed Description

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Conditions

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Glioblastoma Squamous Cell Carcinoma Hodgkin Lymphoma Non-hodgkin Lymphoma Breast Cancer Prostate Cancer Gastric Cancer Ovarian Cancer Acute Leukemia Pancreatic Cancer Spindle Cell Sarcoma Cancer Tumor, Solid Tumor, Brain Esophageal Andeocarcinoma Mixed Phenotype AML Desmoplastic Round Cell Sarcoma

Interventions

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AVM0703

small molecule immunomodulatory drug

Intervention Type DRUG

Hydrocortisone

physiologic circadian glucocorticoid

Intervention Type DRUG

Proton pump inhibitor

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AVM Biotechnology Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edward Loniewski, D.O.

Role: STUDY_DIRECTOR

AVM Biotechnology Inc

Central Contacts

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Mia Lor

Role: CONTACT

12062607770

Theresa A DEISHER, PhD

Role: CONTACT

12068513942

Other Identifiers

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AVM0703-EAP

Identifier Type: -

Identifier Source: org_study_id

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